Associate Director – Aseptic Operational Support

Bristol Myers Squibb

. Provide authoritative technical input on facility and utility design standards, risk assessments, and quality impact assessments .

Posted 10/27/2026full-timeUnited StatesSenior💰 $161,950 - $209,976 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in aseptic facility and utility design, sterility assurance, and microbial control within regulated pharmaceutical environments. Proven ability to lead cross-functional teams and ensure compliance with industry standards and regulatory requirements.

Highest-signal resume keywords

Aseptic Processing ExpertiseSterilization ValidationRegulatory Submission ExperienceContamination Control Strategy DevelopmentLeadership in Quality Assurance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Microbial Risk AssessmentEnvironmental MonitoringFMEAHACCPRisk Ranking and FilteringSterilization TechnologiesAseptic ManufacturingQuality Impact AssessmentTechnical Assessment AuthoringFacility Design Standards

Soft Skills

Cross-Functional PartnershipLeadershipCommunication

Tools & Technologies

FDA Aseptic Processing GuidanceEU GMP Annex 1USPISO 13408PDA Technical Reports

Industry Keywords

Pharmaceutical QualityBiologics ManufacturingContamination ControlRegulatory InspectionsQuality by Design

Tech Stack

Tools & technologies

Airflow

About the role

Key responsibilities & impact

Provide authoritative technical input on facility and utility design standards, risk assessments, and quality impact assessments
Partner with MS&T on technology transfer and process design activities
Partner with Engineering on capital project execution
Serve as the MQSA voice ensuring sterility assurance and microbial control requirements are built into facilities
Review and approve global risk assessments and quality impact assessments associated with contamination events and microbial control failures around Facilities & Utilities
Lead and author high-complexity Business Technical Assessments for regulatory submissions, systemic issue resolution, and cross-site technical alignment
Develop and maintain investigation and inspection-readiness materials for systemic aseptic and microbial control issues
Serve as a subject matter expert on BMS Facilities & Utilities during regulatory inspections
Serve as Global Quality SME for aseptic facility and utility design, reviewing and approving design packages, URS, DQ protocols, and change controls
Define and maintain enterprise-level Quality standards for aseptic facility and utility design
Provide by-design oversight for facility, utility, and equipment changes
Serve as technical authority for aseptic design principles during capital projects, facility modifications, and technology transfers
Integrate contamination control strategy (CCS) requirements into design specifications
Provide Quality oversight for WFI, PW, clean steam, clean compressed gases, and HVAC/clean air systems
Partner with Engineering and Validation teams on IQ/OQ/PQ qualification programs
Champion Quality by Design and risk-based thinking across facility and equipment lifecycle management
Oversee aseptic facility and utility design standards at ExM partners (CMOs/CDMOs), as required
Support quality risk assessments of ExM facility and utility design and drive remediation through the ExM quality governance framework
Own development and governance of enterprise design standards for sterilization technologies, single-use technology, and consumable qualification
Define sterilization validation requirements and risk-based bioburden control strategies
Ensure sterilization design standards remain current with regulatory guidance and industry best practices

Requirements

What you’ll need

Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline
10+ years of progressive experience in sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality
At least 4 years in a leadership or enterprise-level role
Deep technical expertise in aseptic processing, environmental monitoring, contamination control, and microbial risk assessment within a regulated pharmaceutical or biologics manufacturing environment
Demonstrated experience authoring and defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA)
Proven track record in designing or overhauling APS/media fill programs or CCS frameworks at a network or enterprise scale
Hands-on experience with sterilization validation and single-use system qualification
Expert-level knowledge of FDA Aseptic Processing Guidance, EU GMP Annex 1 (2022), USP, ISO 13408 series, and PDA Technical Reports (TR22, TR13, TR70, TR90)
Strong command of contamination control strategy (CCS) development as required under EU GMP Annex 1
Proficiency in FMEA, HACCP, fault tree analysis, risk ranking and filtering
Familiarity with facility design standards, cleanroom classification, and airflow visualization techniques
Experience with EtO, gamma, steam (moist heat), dry heat, and VHP/HPV sterilization technologies
Strong cross-functional partnership skills across Quality, Operations, MS&T, Regulatory, and Supply Chain
Ability to travel up to 25%
Preferred: M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline

Benefits

Comp & perks

Comprehensive wellbeing support, retirement and financial protection benefits
Medical, dental, vision, life and disability insurance offerings
U.S.-based exempt employees: Flexible Time Off (FTO) without a set accrual limit, subject to manager approval
11 paid company holidays each year
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico: 160 hours of paid vacation annually for new hires
3 optional holidays for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico
Additional time-off benefits, depending on eligibility, including paid sick leave
Up to two paid volunteer days per year
Summer hours flexibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees
Additional discretionary incentive cash and stock opportunities
Reasonable workplace accommodations/adjustments and ongoing support